Actively Recruiting
A Prospective, Single-center, Phase II Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Newly Diagnosed Primary Plasma Cell Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-02
20
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of a combination treatment using a VRD-based regimen (Bortezomib, Lenalidomide, and Dexamethasone) along with CAR-T cell therapy and autologous stem cell transplant in Chinese patients newly diagnosed with primary plasma cell leukemia. This prospective, single-arm, single-center phase II study focuses on this aggressive blood cancer to assess the treatment's impact on disease control and patient outcomes. Participants first receive three cycles of induction therapy with the VRD regimen, followed by an initial infusion of CAR-T cells targeting BCMA. After this, they undergo three cycles of consolidation therapy with VR, then an autologous stem cell transplant (ASCT), and a second CAR-T cell infusion. Maintenance therapy with lenalidomide or lenalidomide plus dexamethasone begins approximately 100 days after ASCT. Throughout the study, participants will be closely monitored through various assessments including response rates, safety and tolerability over two years, and progression-free survival at one year. Evaluations occur after induction therapy, after the first CAR-T infusion, at the end of consolidation, and six months after the second CAR-T infusion. Participants will also have laboratory tests and follow-up visits to track disease status and treatment side effects during the study period, which lasts several years.
CONDITIONS
Brief Title
A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent before any study procedures
- Age between 18 and 65 years
- ECOG performance status of 0, 1, or 2
- Life expectancy of at least 3 months
- Definitive diagnosis of primary plasma cell leukemia meeting specified criteria
- No prior anti-myeloma therapy
- Measurable disease with defined levels of M-protein or abnormal free light chain ratio
- Bone marrow sample confirmed BCMA-positive by flow cytometry or pathology
- Routine blood tests meeting specified neutrophil and platelet counts
- Screening blood biochemistry within protocol limits including liver and kidney function
- Ability to take prophylactic anticoagulant therapy as recommended
- Women not breastfeeding or pregnant and agree to avoid pregnancy during and 12 months after study
- Willing and able to complete study procedures and follow-up examinations
You will not qualify if you...
- Secondary plasma cell leukemia
- Central nervous system involvement
- Ineligible for autologous stem cell transplantation due to severe cardiopulmonary disorders
- Known intolerance, allergy, or resistance to study drugs or CAR-T products
- Major surgery within 2 weeks before randomization or not fully recovered
- Unstable or active cardiovascular disease including recent heart attack, uncontrolled hypertension, significant conduction abnormalities, severe heart failure, or recent stroke
- History of serious thrombotic events
- Known HIV positive status
- Active hepatitis B or C infection without confirmed viral clearance
- Ongoing active infection
- Prior malignancies unless disease-free for 5 years
- Pregnant or breastfeeding females
- Active gastrointestinal dysfunction affecting medication intake or absorption
- Any condition affecting study treatment compliance or informed consent
- Contraindications to necessary medications or supportive therapies
- Other medical conditions interfering with participation
- Receiving other experimental therapies
- Unwillingness or inability to comply with study protocol
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants receive 3 cycles of VRD-based regimen including Bortezomib, Lenalidomide, and Dexamethasone over 28-day cycles.
Weekly visits during each 28-day cycle
Duration - Single day
Participants receive the first infusion of autologous BCMA-directed CAR-T cells after induction therapy.
1 visit (in-person) for infusion
Duration - Approximately 3 months
Participants receive 3 cycles of VR-based consolidation therapy following the first CAR-T infusion.
Weekly visits during each 28-day cycle
Duration - Up to several weeks including transplant and immediate recovery
Participants undergo ASCT followed by a second infusion of CAR-T cells.
Multiple visits including hospital stay for ASCT and infusion
Duration - Long-term maintenance starting approximately 3 months post-ASCT
Participants start Lenalidomide or related maintenance therapy beginning on day 100 after ASCT to maintain treatment response.
Periodic visits as per maintenance therapy schedule
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
Research Team
G
Gang An, PhD&MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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